FDA
Enforcement Report
The FDA Enforcement Report is published weekly by the Food and Drug
Administration,
U.S. Public Health Service, Department of Health and Human Services. It contains
information
on actions taken in connection with agency regulatory activities.
ENFORCE
06/30/1993
Recalls and Field Corrections: Foods -- Class II -- 06/30/1993
June 30, 1993 93-26
RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS II
========================
______________
PRODUCT Various cookies, breadsticks, and pretzels:
(a) Animal Crackers
(b) Bulk Oatmeal/Iced Oatmeal Cookies
(c) Choco Chip Cookies
(d) Kraft Pretzels
(e) Kraft Breadsticks
(f) Vanilla Wafers
(g) Butter Cookies
(h) Hershey Tote Bins - Dutch Nuggets
(i) 7 ounce Toasties Marshmallow
(j) 7 ounce Stripes
(k) 2/$1 Shortbread Cookies
(l) Charles Butterscotch Pecan Cookies
(m) Real Chocolate Chip Cookies, 18 ounces
(n) Sysco Homestyle Assorted
(o) Homestyle Assorted
(p) 3# Deluxe. Recall #F-464/479-3.
CODE Item numbers: (a) 11030, 11023, 56092, 975,
14840;
(b) n/a; (c) 10068; (d) 11250; (e) 11251; (f)
12721F, 1107;
(g) 13313F; (h) H9006T; (i) 15208A; (j) 16108A;
(k) 13303F; (l) C4009; (m) DV41497; (n) 1299; (o)
1385; (p) 19325.
MANUFACTURER D.F. Stauffer Biscuit Company, Inc., York,
Pennsylvania.
RECALLED BY Manufacturer, by telephone April 7-8, 1993,
followed by letter dated April 15 or 16, 1993.
Firm-initiated recall complete
DISTRIBUTION East Coast.
QUANTITY 240,000 pounds of product were distributed.
REASON Product was contaminated with plastic styrene
pellets.
_______________
UPDATE Trail Mix products which appeared in the June 23,
1993 Enforcement Report should read:
PRODUCT: Trail Mix Products: (a) California
Aloha Trail Mix; (b) Royal Deluxe Trail Mix,
Recall #F-482/483-3.
RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS III
=======================
______________
PRODUCT Novie Chunk Light Canned Tuna Fish, in 6.125 ounce
cans. Recall #F-361-3.
CODE Lot #2C313 CLVYX.
MANUFACTURER Crown Brands, Inc., Newark, New Jersey.
RECALLED BY Manufacturer, by letter April 23, 1993. Firm-
initiated recall complete.
DISTRIBUTION New York.
QUANTITY 153 cases (48 cans per case) were distributed.
REASON Product is decomposed.
RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS II
========================
______________
PRODUCT Enconopred Plus (Prednisolone Acetate) 1%, 10 ml
sterile Rx ophthalmic suspension. Recall #D-283-
3.
CODE 2RLDV.
MANUFACTURER Alcon (PR), Inc., Humacao, Puerto Rico.
RECALLED BY Alcon Laboratories, Inc., Fort Worth, Texas, by
visit May 27, 1993. Firm-initiated recall
complete.
DISTRIBUTION South Dakota.
QUANTITY Approximately 200 units were distributed.
REASON Lack of assurance of sterility.
RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS II
======================
_______________
PRODUCT Software Versions 3.0 and 3.1 for the Omnitro
Model 2000 High Dose Rate Remote Afterloader
System, used to administer radiation
interstitially directly to the tumor bed of a
cancer patient. Recall #Z-546/547-3.
CODE Serial numbers: 102, 104, 109, 114, 115, 116,
1212, 132, 134. (All units with active source
wires when the bulletin was issued).
MANUFACTURER Omnitro International, Inc., Houston, Texas.
RECALLED BY Manufacturer, by technical bulletin dated March
19, 1993. Firm-initiated field correction
ongoing.
DISTRIBUTION Arizona, California, Florida, Louisiana,
Mississippi, New Jersey, Pennsylvania, Texas.
QUANTITY 10 units were distributed.
REASON If the function keys are randomly depressed or
control keys are pressed in conjunction with other
keys totally unexpected results may occur. These
may include lock-up and/or interference with the
movement or retraction of the source wire or
premature termination of treatment.
_______________
PRODUCT Biconvex Posterior Chamber One-Piece Intraocular
Lenses, Model 815A with powers 25.00, 24.00,
23.00, 22.50, 22.00, 21.00, 20.50, 19.50, 19.00,
18.50, 16.50, 14.50, 13.50, 11.00. Recall #Z-550-
3.
CODE Serial numbers: 25.0 power --
2133313-6, 2133314-4, 2133315-2, 2133316-0,
2133317-8, 2133318-6, 2133319-4, 2133320-1,
2133321-9, 2133322-7, 2133323-5, 2133324-3,
2133325-1, 2133326-9, 2133327-7, 2133328-5,
2133329-3, 2133330-0, 2133331-8, 2133332-6,
2133333-4, 2133334-2, 2133335-0, 2133336-8,
2133337-6, 2133338-4, 2133339-2, 2133340-9,
2133341-7.
24.00 power -- 2133393-0, 2133394-8, 2133395-6,
233396-4, 2133397-2, 2133398-0, 2133399-8,
2133400-3, 2133401-1, 2133402-9, 2133403-7,
2133404-5, 2133405-3, 2133406-1, 2133407-9,
2133408-7, 2133409-5, 2133410-2, 2133411-0,
2133412-8, 2133413-6, 2133414-4, 2133415-2,
2133416-0, 2133417-8, 2133418-6.
23.00 power -- 2133284-3, 2133285-1, 2133286-9,
2133287-7, 2133288-5, 2133289-3, 2133290-0,
2133291-8, 2133292-6, 2133293-4, 2133294-2,
2133295-0, 2133296-8, 2133297-6, 2133298-4,
2133299-2, 2133300-7, 2133301-5, 2133302-3,
2133303-1, 2133304-9, 2133305-7, 2133306-5,
2133307-3, 2133308-1, 2133309-9, 2133310-6,
2133311-4, 2133312-2.
22.50 power -- 2133466-4, 2133467-2, 2133468-0,
2133469-8, 2133470-5, 2133471-3, 2133472-1,
2133473-9, 2133474-7, 2133475-5, 2133476-3,
2133477-1, 2133478-9, 2133479-7, 2133480-4,
2133481-2, 2133482-0, 2133483-8, 2133484-6,
2133485-4, 2133486-2.
22.00 power -- 2133025-3, 2133026-1, 2133027-9,
2133028-7, 2133029-5, 2133030-2, 2133031-0,
2133032-8, 2133033-6, 2133034-4, 2133035-2,
2133036-0, 2133037-8, 2133038-6, 2133039-4,
2133040-1, 2133041-9, 2133042-7, 2133043-5,
2133044-3, 2133045-1, 2133046-9, 2133047-7,
2133048-5, 2133049-3, 2133050-0, 2133051-8,
2133052-6, 2133053-4, 2133054-2, 2133055-0,
2133056-8, 2133057-6, 2133058-4, 2133059-2,
2133060-9, 2133152-4, 2133153-2, 2133154-0,
2133155-8, 2133156-6, 2133157-4, 2133158-2,
2133159-0, 2133160-7, 2133161-5, 2133162-3,
2133163-1, 2133164-9, 2133165-7, 2133166-5,
2133167-3, 2133168-1, 2133169-9,
2133525-3, 2133526-1, 2133527-9, 2133528-7,
2133529-5, 2133530-2, 2133531-0, 2133532-8,
2133533-6, 2311534-4, 2133535-2, 2133536-0,
2133537-8, 2133538-6, 2133539-4, 2133540-1,
2133541-9, 2133542-7, 2133543-5, 2133544-3.
21.00 power: 2133342-3, 2133343-1, 2133344-9,
2133345-7, 2133346-5, 2133347-3, 2133348-1,
2133349-9, 2133350-6, 2133351-4, 2133352-2,
2133353-0, 2133354-8, 2133355-6, 2133356-4,
2133357-2, 2133358-0, 2133359-8, 2133360-5,
2133361-3, 2133362-1, 2133363-9, 2133364-7,
2133365-5, 2133370-4, 2133371-2, 2133372-0.
20.50 power: 2133597-1, 2133598-9, 2133602-8,
2133551-7, 2133552-5, 2133553-3, 2133554-1,
2133555-9, 2133556-7, 2133557-5, 2133558-3,
2133559-1, 2133560-8, 2133561-6, 2133562-4,
2133563-2, 2133564-0, 2133565-8, 2133566-6,
2133567-4, 2133568-2, 2133599-7, 2133600-2,
2133601-0, 2133603-6, 2133604-4, 2133605-2,
2133606-0, 2133607-8, 2133608-6, 2133609-4,
2133610-1, 2133611-9, 2133545-0, 2133546-8,
2133548-4, 2133547-6, 2133549-2, 2133550-9.
19.50 power: 2133233-4, 2133234-2, 2133235-0,
2133236-8, 2133237-6, 2133238-4, 2133239-2,
2133240-9, 2133241-7,
2133242-5, 2133243-3, 2133244-1, 2133245-9,
2133246-7, 2133247-5, 2133248-3, 2133249-1,
2133250-8, 2133251-6, 2133252-4, 2133253-2.
19.00 power: 2133061-4, 21330062-2, 2133063-0,
2133064-8, 2133065-6, 2133066-4, 2133067-2,
2133068-0, 2133069-8, 2133070-5, 2133071-3,
2133072-1, 2133073-9, 2133074-7, 2133075-5,
2133076-3, 2133077-1, 2133078-9, 2133079-7,
2133080-4, 2133081-2, 2133082-0, 2133083-8,
2133084-6, 2133085-4, 2133086-2, 2133087-0,
2133088-8, 2133089-6, 2133090-3, 2133091-1,
2133092-9, 2133093-7, 2133094-5.
18.50 power: 2133170-0, 2133171-8, 2133172-6,
2133173-4, 2133174-2, 2133175-0, 2133176-8,
2133177-6, 2133178-4, 2133179-2, 2133180-9,
2133181-7, 2133182-5, 2133183-3, 2133184-1,
2133185-9, 2133186-7, 2133187-5, 2133188-3,
2133189-1, 2133190-8, 2133191-6, 2133192-4,
2133193-2, 2133194-0, 2133195-8, 2133196-6,
2133197-4, 2133198-2, 2133199-0, 2133200-5,
2133373-0, 2133374-8, 2133375-6, 2133376-4,
2133377-2, 2133378-0, 2133379-8, 2133380-5,
2133381-3, 2133382-1, 2133383-9, 2133384-7,
2133385-5, 2133386-3, 2133387-1, 2133388-9,
2133389-7, 2133390-4, 2133391-2, 2133392-0.
16.50 power: 2133255-4, 2133256-2, 2133257-0,
2133258-8, 2133259-6, 2133260-3, 2133261-1,
2133262-9, 2133263-7, 2133264-5, 2133265-3,
2133266-1, 2133267-9, 2133268-7, 2133269-5,
2133270-2, 2133271-0, 2133272-8, 2133273-6,
2133274-4, 2133275-2, 2133276-0, 2133277-8,
2133278-6, 2133279-4, 2133280-1, 2133281-9,
2133282-7, 2133283-5.
14.50 power: 2133487-7, 2133488-5, 2133489-3,
2133494-2, 2133490-0, 2133491-8, 2133492-6,
2133493-4, 2133495-0, 2133496-8, 2133497-6,
2133498-4, 2133499-2, 2133500-7, 2133501-5,
2133502-3, 2133503-1, 2133504-9, 2133505-7,
2133506-5, 2133507-3, 2133508-1, 2133509-9,
2133510-6,
2133511-4, 2133512-2, 2133513-0, 2133514-8,
2133515-6, 2133516-4, 2133517-2, 2133518-0, 2133519-8,
2133520-5, 2133521-3, 2133522-1, 2133523-9, 2133524-7.
13.50 power: 2133575-2, 2133576-0, 2133577-8,
2133578-6, 2133579-4, 2133580-1, 2133581-9,
2133582-7, 2133583-5, 2133584-3, 2133586-9,
2133587-7, 2133585-1, 2133588-5, 2133589-3,
2133590-0, 2133591-8, 2133592-6, 2133593-4,
2133594-2, 2133595-0, 2133596-8, 2133569-5,
2133570-2, 2133571-0, 2133572-8, 2133573-6,
2133574-4.
11.00 power: 2133419-1, 2133420-8, 2133421-6,
2133422-4, 2133423-2, 2133424-0, 2133425-8,
2133426-6, 2133427-4, 2133428-2, 2133429-0,
2133433-1, 2133430-7, 2133431-5, 2133432-3,
2133434-9, 2133435-7, 2133436-5, 2133437-3,
2133438-1, 2133439-9, 2133440-6, 2133441-4,
2133442-2.
MANUFACTURER Kabi Pharmacia Ophthalmic, Inc., Monrovia,
California.
RECALLED BY Manufacturer, by telephone September 3, 1992,
followed by visit. Firm-initiated recall
complete.
DISTRIBUTION Arizona, California, Colorado, Idaho, Kansas,
Louisiana, Oregon, Texas, Utah, Washington state.
QUANTITY 90 units were distributed.
REASON Product contains an incorrect lens graphic on the
end of the package label.
_______________
PRODUCT Commercial Sun Tanning Beds manufactured by Alisun
America, Alisun Professional and Alisun Holland
for distribution by ETS, Inc., Indianapolis, IN:
(a) Sunquest Wolff Super ZX 41 (digital timer, 41
Wolff System lamps)
Sunquest Wolff Super ZX 41-2F (digital timer, 41
Wolff System lamps, 2 400-watt high-speed face
tanners)
Sunquest Wolff Super ZX 30 (30 Wolff System lamps)
Sunquest Wolff Super ZX 30-F (30 Wolff System
lamps, 1 400-watt high-speed face tanner)
Sunquest Wolff Super ZX 30-2F (30 Wolff System
lamps, 2 400-watt high-speed face tanners).
Recall #Z-560/561-3.
CODE All serial numbers.
MANUFACTURER Alisun America, Ltd., McHenry, Illinois.
RECALLED BY Manufacturer. FDA approved the firm's corrective
action plan June 4, 1993. Firm-initiated field
correction ongoing.
DISTRIBUTION Nationwide, Canada, Japan.
QUANTITY 29 - ZX 41, 18 - ZX 41-2F, 196 - ZX 30, 50 - ZX
30F, and 136 ZX 30-2F sunbeds were distributed,
with all of the units estimated to remain on the
market.
REASON Noncompliance with the performance standards for
sunlamp products in that timers are capable of
being set for exposure times exceeding the
products' maximum recommended exposure times.
_______________
PRODUCT Ohmeda Modulus CD Anesthesia Systems,
computer-based integrated anesthesia systems with
Central Displays. Recall #Z-562-3.
CODE Stock Numbers:
0397-2012-043 MOD CD 3G LH O2 N2O AIR 220V 10A ISO
NETH
0397-2080-000 MOD CD 3G O2 N2O AIR 220V 10A KUWAIT
0397-2080-001 MOD CD 4G LH O2 N2O AIR CO2 120V 15A
ISO
0397-2080-002 MOD CD 3G O2 N2O AIR 100V 15A JAPAN
0397-2112-112 CD MFG BUILD 2/MODII+ 3G AIR O2 N2O
1202-8173-000 MOD CD UPRIGHT/PNEUM 3G O2 N2O AIR
JAPAN
1202-9000-000 MOD CD 3G O2 N2O AIR 120V 15A
1202-9001-000 MOD CD 4G O2 N2O AIR HELIOX 120V 15A
1202-9002-000 MOD CD 4G O2 N2O AIR CO2 120V 15A
51202-9003-000 MOD CD 4G UK ISO O2 N2O AIR CO2
240V 10A
1202-9004-000 MOD CD 3G O2 N2O AIR 220V 10A ISO
NETH
1202-9005-000 MOD CD 3G O2 N2O AIR 120V 12A CANADA
1202-9007-000 MOD CD 3G AIR 220V 10A IEC GER
1202-9008-000 MOD CD 3G O2 N2O AIR 100V 15A JAPAN
1202-9009-000 MOD CD 4G CO2 240V 10A IEC UK
1202-9016-000 MOD CD 3G AIR 220V 10A IEC NETH
1202-9017-000 MOD CD 3G AIR 220V 10A IEC FRENCH
1202-9018-000 MOD CD 3G AIR 220V 10A IEC ITALIAN
1202-9019-000 MOD CD 3G AIR 220V 10A IEC SPANISH
1202-9021-000 MOD CD 3G AIR 220V 10A IEC AUSTRIA
Serial Numbers: ABZU00426 through ABZW00240.
MANUFACTURER Ohmeda, Madison, Wisconsin.
RECALLED BY Manufacturer, by letter May 13, 1993. Firm-
initiated recall ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY 622 units were distributed.
REASON The product can provide false blood pressure
readings during surgery. Electrical noise can
cause the control circuit of the product's non-
invasive blood pressure module to stop taking
intermittent blood pressure readings, and the most
recent blood pressure readings becomes locked into
the display, with no indication of any error.
_______________
PRODUCT Focus Clear Contact Lenses, in single foil trial
packages. Recall #Z-566-3.
CODE Lot 3014751 EXP 5/98.
MANUFACTURER Ciba Vision, Atlanta, Georgia.
RECALLED BY Manufacturer, by letter April 23, 1993. Firm-
initiated recall ongoing.
DISTRIBUTION Nationwide, Canada.
QUANTITY 362 lenses were distributed.
REASON The label indicates an incorrect base curve, 8.9
instead of 8.6.
_______________
PRODUCT Promotional materials for Miraflow Extra Strength
Daily Cleaner. Sales Aid entitled "Go Beyond
Clean", a letter from CIBA Vision; and 2 journal
article reprints (Journal of the American
Optometric Association, Ghajar et al, 1989; CLAO
Journal, Penley et al, 1989). Recall #Z-571-3.
CODE None.
MANUFACTURER CIBA Vision Corporation, Duluth, Georgia.
RECALLED BY Manufacturer, by returns and letter April 2, 1993.
February 19, 1993. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY Unknown.
REASON The promotional material's claim for use as a
disinfectant exceed the product's PMA approved
indication as a daily cleaner for contact lenses.
RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS III
=====================
_______________
PRODUCT Raichem Lipase Reagent In-vitro Diagnostic Test
Kit, used for the quantitative enzymatic
measurement of Lipase activity in human serum.
Recall #Z-496/497-3.
CODE Product #85279 (5 x 10 ml pack), lot 84001 and
Product 85284 (5 x 30 ml pack), lot 84002.
MANUFACTURER Toyo Jozo, Company, Ltd., Shizuoka, Japan.
RECALLED BY Reagents Applications, Inc., San Diego,
California, by telephone late January 1992 or
early February 1992. Firm-initiated recall
ongoing.
DISTRIBUTION California, Ohio, Illinois, Florida, Portugal,
Canada, Ecuador, Greece.
QUANTITY 1 30-ml pack and 89 10-ml packs were distributed.
REASON There is a vial to vial variation in the
concentration of lyophilized Lipase Standard, Lot
#4747, included in each kit and/or the value of
the Lipase Standard was incorrectly assigned.
________________
PRODUCT Sterile Cleaning Solution for Soft (hydrophilic)
contact lenses, in 1 fluid ounce containers with
the following labels:
(a) Revco Sterile Cleaning Solution, distributed
by Revco D.S., Inc.; (b) Thrifty Sterile Cleaning
Solution, distributed by Thrifty Drug Stores, a
Division of Thrifty Corporation; (c) Fays Quality
Sterile Cleaning Solution, distributed by Fay's
Drug Stores, Division of Fay's Inc.; (d) Genovese
Sterile Cleaning Solution, distributed by Genovese
Drug Stores, Inc. Recall #Z-567/570-3.
CODE EC0011C EXP 5/8/92, E0020/E0020A EXP 10/22/92.
MANUFACTURER Paco Pharmaceutical Services, Inc., Lakewood, New
Jersey.
RECALLED BY Manufacturer, by letter May 8, 1992. Firm-
initiated recall ongoing.
DISTRIBUTION California, Michigan, North Carolina, Nevada, New
York, Pennsylvania, South Carolina.
QUANTITY (a) 1,170 cases; (b) 2,911 cases were distributed.
REASON The firm's tests detected a low sorbic acid value
which could cause yellowing of the solution.
SEIZURES:
================================================================
_______________
PRODUCT Frozen tuna steaks (92-556-582).
CHARGE Adulterated - The article consists in whole or in
part of a decomposed substance and is otherwise
unfit for food because it is rancid.
FIRM Transfresh, Miami, Florida.
FILED February 11, 1993; U.S. District Court for the
Southern District of Florida; Civ.
93-0322-CIV-UNGARO; FDC #66654.
SEIZED March 11, 1993 - goods valued at approximately $715.
_______________
PRODUCT Dried garlic bulbs (93-594-211, et al.).
CHARGES Adulterated - The article consists in part of filthy
and decomposed substances. Misbranded - The article
is in package form and it fails to bear a label
containing: the name and place of business of the
manufacturer, packer, or distributor; and a
declaration of net quantity of contents
in terms of avoirdupois pound and ounce as required.
FIRM Fundora Produce, Miami, Florida.
FILED April 7, 1993; U.S. District Court for the
Southern District of Florida; Civil
#93-0663-CIV-UNGARO-BENAGES; FDC #66682.
SEIZED May 10, 1993 - goods valued at approximately $708.
_______________
PRODUCT MLC Normal Serum in vitro diagnostic device
(93-635-542).
CHARGES Adulterated - The article is a class III medical
device which does not have in effect the required
approved premarket approval application. The
article is further adulterated because the
methods used in, and the facilities and controls
used for, its manufacture, packing, and storage
are not in conformity with current good
manufacturing practice requirements for devices.
Misbranded - The article's labeling contains a
statement which is false and misleading and
otherwise contrary to fact. The article's
labeling also fails to bear adequate directions
for use for the purposes for which it is
intended.
FIRM RJO Biologicals, Inc., Kansas City, Missouri.
FILED June 18, 1993; U.S. District Court for the Western
District
of Missouri, Western Division; Civ. #93-0591-CV-W-8;
FDC #66711.
SEIZED June 24, 1993 - goods valued at approximately
$13,260.
-8-
END OF ENFORCEMENT REPORT FOR JUNE 30, 1993. BLANK PAGES MAY FOLLOW.
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